Project Medtech

Episode 278 | Staci Miller, Founder of Gen UX Consulting | The First Five Things You Need to Know About Human Factors Validation Testing

September 14, 2026·24 min
Episode Description from the Publisher

Staci Miller, founder of Gen UX Consulting, joins Duane Mancini for a rapid-fire rundown of the first five things you need to know about human factors validation testing, from the risk documents nobody prioritizes but everyone needs, to the razor-thin line between a task sheet and a leading question that could invalidate your study, to why a 300-page report might be doing you more harm than good. Packed with hard-won insight from nearly 15 years in the field, this episode gives you a practical playbook for getting your validation study and your FDA submission right.Staci Miller LinkedInGen UX LinkedInGen UX WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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